Comparing One-Stage Prepectoral Implant Breast Reconstruction to Two-Stage ExpanderImplant Reconstruction with Radiotherapy in Breast Cancer Patients A Prospective Study

What this Trial Is About

This research aims to evaluate the effectiveness and safety of two types of breast reconstruction in women with breast cancer who need postoperative radiotherapy. It focuses on comparing immediate one-stage prepectoral prosthetic reconstruction with two-stage expanderprosthesis reconstruction in patients diagnosed with breast cancer without distant metastasis. The study will record changes in quality of life using BREAST-Q scores, as well as complications, capsular contracture, and tumor safety over time. Participants will undergo nipple-sparing or skin-sparing mastectomy followed by either immediate prepectoral implant reconstruction or two-stage reconstruction involving a tissue expander first, then permanent implant after radiotherapy. Both surgical approaches allow open, endoscopic, or robotic techniques, with or without mesh use. Radiotherapy timing differs immediate reconstruction patients receive radiotherapy after implant placement, while two-stage reconstruction patients receive radiotherapy with the expander in place before implant exchange six or more months later. Throughout the study, patients will be monitored with quality of life assessments before surgery and one year afterward using BREAST-Q scores. Secondary outcomes include breast reconstruction success rates, surgical complications, aesthetic evaluations by doctors, capsular contracture development, nipple and skin sensation, and long-term tumor safety measured by disease-free and overall survival up to five years. The study plans to enroll over 104 patients, with participation lasting at least one year for primary outcomes and longer for survival follow-up.

Efficacy and Safety of Prepectoral Prosthesis Immediate One-Stage Breast Reconstruction Versus Two-Stage Expander/Prosthesis Reconstruction in Postoperative Adjuvant Radiotherapy Breast Cancer Patients: A Prospective, Single-Center, Cohort Study